[Congressional Record: September 26, 2006 (House)]
[Page H7445-H7450]
BIODEFENSE AND PANDEMIC VACCINE AND DRUG DEVELOPMENT ACT OF 2006
Mr. DEAL of Georgia. Mr. Speaker, I move to suspend the rules and
pass the bill (H.R. 5533) to prepare and strengthen the biodefenses of
the United States against deliberate, accidental, and natural outbreaks
of illness, and for other purposes, as amended.
The Clerk read as follows:
H.R. 5533
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Biodefense and Pandemic
Vaccine and Drug Development Act of 2006''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Biomedical Advanced Research and Development Authority;
National Biodefense Science Board.
Sec. 4. Clarification of countermeasures covered by Project BioShield.
Sec. 5. Technical assistance.
Sec. 6. Procurement.
SEC. 3. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY; NATIONAL BIODEFENSE SCIENCE BOARD.
Title III of the Public Health Service Act (42 U.S.C. 241
et seq.) is amended by inserting after section 319K the
following:
``SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT
AUTHORITY.
``(a) Biomedical Advanced Research and Development
Authority.--
``(1) Establishment.--There is established within the
Department of Health and Human Services the Biomedical
Advanced Research and Development Authority.
``(2) In general.--The Secretary shall coordinate and
oversee the acceleration of countermeasure and product
advanced research and development by--
``(A) facilitating collaboration among the Department of
Health and Human Services, other Federal agencies, relevant
industries, academia, and other persons, with respect to such
advanced research and development;
``(B) promoting countermeasure and product advanced
research and development;
``(C) facilitating contacts between interested persons and
the offices or employees authorized by the Secretary to
advise such persons regarding requirements under the Federal
Food, Drug, and Cosmetic Act and under section 351 of this
Act; and
``(D) promoting innovation to reduce the time and cost of
countermeasure and product advanced research and development.
``(3) Director.--The BARDA shall be headed by a Director
(referred to in this section as the `Director') who shall be
appointed by the Secretary and to whom the Secretary shall
delegate such functions and authorities as necessary to
implement this section.
``(4) Duties.--
``(A) Collaboration.--To carry out the purpose described in
paragraph (2)(A), the Secretary shall--
``(i) facilitate and increase the expeditious and direct
communication between the Department of Health and Human
Services and relevant persons with respect to countermeasure
and product advanced research and development, including by--
``(I) facilitating such communication regarding the
processes for procuring such advanced research and
development with respect to qualified countermeasures and
qualified pandemic or epidemic products of interest; and
``(II) soliciting information about and data from research
on potential qualified countermeasures and qualified pandemic
or epidemic products and related technologies;
``(ii) at least annually--
``(I) convene meetings with representatives from relevant
industries, academia, other Federal agencies, international
agencies as appropriate, and other interested persons;
``(II) sponsor opportunities to demonstrate the operation
and effectiveness of relevant biodefense countermeasure
technologies; and
``(III) convene such working groups on countermeasure and
product advanced research and development as the Secretary
may determine are necessary to carry out this section; and
``(iii) carry out the activities described in section 6 of
the Biodefense and Pandemic Vaccine and Drug Development Act
of 2006.
``(B) Support advanced research and development.--To carry
out the purpose described in paragraph (2)(B), the Secretary
shall--
``(i) conduct ongoing searches for, and support calls for,
potential qualified countermeasures and qualified pandemic or
epidemic products;
``(ii) direct and coordinate the countermeasure and product
advanced research and development activities of the
Department of Health and Human Services;
``(iii) establish strategic initiatives to accelerate
countermeasure and product advanced research and development
and innovation in such areas as the Secretary may identify as
priority unmet need areas; and
``(iv) award contracts, grants, cooperative agreements, and
enter into other transactions, for countermeasure and product
advanced research and development.
``(C) Facilitating advice.--To carry out the purpose
described in paragraph (2)(C) the Secretary shall--
``(i) connect interested persons with the offices or
employees authorized by the Secretary to advise such persons
regarding the regulatory requirements under the Federal Food,
Drug, and Cosmetic Act and under section 351 of this Act
related to the approval, clearance, or licensure of qualified
countermeasures or qualified pandemic or epidemic products;
and
``(ii) ensure that, with respect to persons performing
countermeasure and product advanced research and development
funded under this section, such offices or employees provide
such advice in a manner that is ongoing and that is otherwise
designated to facilitate expeditious development of qualified
countermeasures and qualified pandemic or epidemic products
that may achieve such approval, clearance, or licensure.
``(D) Supporting innovation.--To carry out the purpose
described in paragraph (2)(D), the Secretary may award
contracts, grants, and cooperative agreements, or enter into
other transactions, such as prize payments, to promote--
``(i) innovation in technologies that may assist
countermeasure and product advanced research and development;
``(ii) research on and development of research tools and
other devices and technologies; and
``(iii) research to promote strategic initiatives, such as
rapid diagnostics, broad spectrum antimicrobials, and vaccine
manufacturing technologies.
``(5) Transaction authorities.--
``(A) Other transactions.--In carrying out the functions
under subparagraph (B) or (D) of paragraph (4), the Secretary
shall have authority to enter into other transactions for
countermeasure and product advanced research and development.
[[Page H7446]]
``(B) Expedited authorities.--
``(i) In general.--In awarding contracts, grants, and
cooperative agreements, and in entering into other
transactions under subparagraph (B) or (D) of paragraph (4),
the Secretary shall have the expedited procurement
authorities, the authority to expedite peer review, and the
authority for personal services contracts, supplied by
subsections (b), (c), and (d) of section 319F-1.
``(ii) Application of provisions.--Provisions in such
section 319F-1 that apply to such authorities and that
require institution of internal controls, limit review,
provide for Federal Tort Claims Act coverage of personal
services contractors, and commit decisions to the discretion
of the Secretary shall apply to the authorities as exercised
pursuant to this paragraph.
``(iii) Authority to limit competition.--For purposes of
applying section 319F-1(b)(1)(D) to this paragraph, the
phrase `BioShield Program under the Project BioShield Act of
2004' shall be deemed to mean the countermeasure and product
advanced research and development program under this section.
``(iv) Availability of data.--The Secretary may require
that, as a condition of being awarded a contract, grant,
cooperative agreement, or other transaction under
subparagraph (B) or (D) of paragraph (4), a person make
available to the Secretary on an ongoing basis, and submit
upon request to the Secretary, relevant data related to or
resulting from countermeasure and product advanced research
and development carried out pursuant to this section.
``(C) Advance payments; advertising.--The authority of the
Secretary to enter into contracts under this section shall
not be limited by section 3324(a) of title 31, United States
Code, or by section 3709 of the Revised Statutes of the
United States (41 U.S.C. 5).
``(D) Milestone-based payments allowed.--In awarding
contracts, grants, and cooperative agreements, and in
entering into other transactions, under this section, the
Secretary may use milestone-based awards and payments.
``(E) Foreign nationals eligible.--The Secretary may under
this section award contracts, grants, and cooperative
agreements to, and may enter into other transactions with,
highly qualified foreign national persons outside the United
States, alone or in collaboration with American participants,
when such transactions may inure to the benefit of the
American people and are consistent with National security.
``(F) Establishment of advanced research centers.--The
Secretary may establish one or more federally-funded research
and development centers, or university-affiliated research
centers in accordance with section 303(c)(3) of the Federal
Property and Administrative Services Act of 1949 (41 U.S.C.
253(c)(3)), provided that such centers are consistent and
complementary with the duties described in paragraph (4), and
are consistent and complementary with, and deemed necessary
after considering the availability of, existing federally-
supported basic research programs.
``(6) Vulnerable populations.--In carrying out the
functions under this section, the Secretary may give priority
to the advanced research and development of qualified
countermeasures and qualified pandemic or epidemic products
that are likely to be safe and effective with respect to the
emergency health security needs of children and other
vulnerable populations.
``(7) Personnel authorities.--
``(A) Specially qualified scientific and professional
personnel.--In addition to any other personnel authorities,
the Secretary may--
``(i) without regard to those provisions of title 5, United
States Code, governing appointments in the competitive
service, appoint highly qualified individuals to scientific
or professional positions in BARDA, such as program managers,
to carry out this section; and
``(ii) compensate them in the same manner in which
individuals appointed under section 9903 of such title are
compensated, without regard to the provisions of chapter 51
and subchapter III of chapter 53 of such title relating to
classification and General Schedule pay rates.
``(B) Special consultants.--In carrying out this section,
the Secretary may--
``(i) appoint special consultants pursuant to section
207(f); and
``(ii) accept voluntary and uncompensated services.
``(c) Inapplicability of Certain Provisions.--
``(1) Disclosure.--
``(A) In general.--The Secretary shall withhold from
disclosure under section 552 of title 5, United States Code,
specific technical data or scientific information that is
created or obtained during the countermeasure and product
advanced research and development funded by the Secretary
that reveal vulnerabilities of existing medical or public
health defenses against biological, chemical, nuclear, or
radiological threats. Such information shall be deemed to be
information described in section 552(b)(3) of title 5, United
States Code.
``(B) Oversight.--Information subject to nondisclosure
under subparagraph (A) shall be reviewed by the Secretary
every 5 years to determine the relevance or necessity of
continued nondisclosure.
``(2) Federal advisory committee act.--Section 14 of the
Federal Advisory Committee Act (5 U.S.C. App.) shall not
apply to a working group of BARDA or to the National
Biodefense Science Board under section 319M.
``(d) Authorization of Appropriations.--For the purpose of
carrying out advanced research and development under this
section, there are authorized to be appropriated $160,000,000
for each of the fiscal years 2007 and 2008. Such
authorizations are in addition to other authorizations of
appropriations that are available for such purpose. Amounts
appropriated under the preceding sentence are available until
expended.
``(e) Definitions.--For purposes of this section:
``(1) BARDA.--The term `BARDA' means the Biomedical
Advanced Research and Development Authority.
``(2) Other transactions.--The term `other transactions'
means transactions, other than procurement contracts, grants,
and cooperative agreements, such as the Secretary of Defense
may enter into under section 2371 of title 10, United States
Code.
``(3) Qualified countermeasure.--The term `qualified
countermeasure' has the meaning given such term in section
319F-1.
``(4) Qualified pandemic or epidemic product.--The term
`qualified pandemic or epidemic product' has the meaning
given the term in section 319F-3.
``(5) Advanced research and development.--
``(A) In general.--The term `advanced research and
development' means, with respect to a product that is or may
become a qualified countermeasure or a qualified pandemic or
epidemic product, activities that predominantly--
``(i) are conducted after basic research and preclinical
development of the product; and
``(ii) are related to manufacturing the product on a
commercial scale and in a form that satisfies the regulatory
requirements under the Federal Food, Drug, and Cosmetic Act
or under section 351 of this Act.
``(B) Activities included.--The term under subparagraph (A)
includes--
``(i) testing of the product to determine whether the
product may be approved, cleared, or licensed under the
Federal Food, Drug, and Cosmetic Act or under section 351 of
this Act for a use that is or may be the basis for such
product becoming a qualified countermeasure or qualified
pandemic or epidemic product, or to help obtain such
approval, clearance, or license;
``(ii) design and development of tests or models, including
animal models, for such testing;
``(iii) activities to facilitate manufacture of the product
on a commercial scale with consistently high quality, as well
as to improve and make available new technologies to increase
manufacturing surge capacity;
``(iv) activities to improve the shelf-life of the product
or technologies for administering the product; and
``(v) such other activities as are part of the advanced
stages of testing, refinement, improvement, or preparation of
the product for such use and as are specified by the
Secretary.
``(6) Research tool.--The term `research tool' means a
device, technology, biological material, reagent, animal
model, computer system, computer software, or analytical
technique that is developed to assist in the discovery,
development, or manufacture of qualified countermeasures or
qualified pandemic or epidemic products.
``(7) Program manager.--The term `program manager' means an
individual appointed to carry out functions under this
section and authorized to provide project oversight and
management of strategic initiatives.
``(8) Person.--The term `person' includes an individual,
partnership, corporation, association, entity, or public or
private corporation, and a Federal, State, or local
government agency or department.
``SEC. 319M. NATIONAL BIODEFENSE SCIENCE BOARD AND WORKING
GROUPS.
``(a) In General.--
``(1) Establishment and function.--The Secretary shall
establish the National Biodefense Science Board (referred to
in this section as the `Board') to provide expert advice and
guidance to the Secretary on scientific, technical and other
matters of special interest to the Department of Health and
Human Services regarding current and future chemical,
biological, nuclear, and radiological agents, whether
naturally occurring, accidental, or deliberate.
``(2) Membership.--The membership of the Board shall be
comprised of individuals who represent the Nation's
preeminent scientific, public health, and medical experts, as
follows--
``(A) such Federal officials as the Secretary may determine
are necessary to support the functions of the Board;
``(B) four individuals representing the pharmaceutical,
biotechnology, and device industries;
``(C) four individuals representing academia; and
``(D) five other members as determined appropriate by the
Secretary.
``(3) Term of appointment.--A member of the Board described
in subparagraph (B), (C), or (D) of paragraph (2) shall serve
for a term of 3 years, except that the Secretary may adjust
the terms of the initial Board appointees in order to provide
for a staggered term of appointment for all members.
``(4) Consecutive appointments; maximum terms.--A member
may be appointed to serve not more than 3 terms on the Board
and may serve not more than 2 consecutive terms.
``(5) Duties.--The Board shall--
``(A) advise the Secretary on current and future trends,
challenges, and opportunities presented by advances in
biological and life sciences, biotechnology, and genetic
engineering with respect to threats to biodefense or public
health security posed by naturally occurring infectious
diseases and chemical, biological, radiological, and nuclear
agents;
``(B) at the request of the Secretary, review and consider
any information and findings received from the working groups
established under subsection (b); and
``(C) at the request of the Secretary, provide
recommendations and findings for expanded, intensified, and
coordinated biodefense research and development activities.
``(6) Meetings.--
[[Page H7447]]
``(A) Initial meeting.--Not later than one year after the
date of enactment of the Biodefense and Pandemic Vaccine and
Drug Development Act of 2006, the Secretary shall hold the
first meeting of the Board.
``(B) Subsequent meetings.--The Board shall meet at the
call of the Secretary, but in no case less than twice
annually.
``(7) Vacancies.--Any vacancy in the Board shall not affect
its powers, but shall be filled in the same manner as the
original appointment.
``(8) Chairperson.--The Secretary shall appoint a
chairperson from among the members of the Board.
``(9) Powers.--
``(A) Hearings.--The Board may hold such hearings, sit and
act at such times and places, take such testimony, and
receive such evidence as the Board considers advisable to
carry out this subsection.
``(B) Postal services.--The Board may use the United States
mails in the same manner and under the same conditions as
other departments and agencies of the Federal Government.
``(10) Personnel.--
``(A) Employees of the federal government.--A member of the
Board that is an employee of the Federal Government may not
receive additional pay, allowances, or benefits by reason of
the member's service on the Board.
``(B) Other members.--A member of the Board that is not an
employee of the Federal Government may be compensated at a
rate not to exceed the daily equivalent of the annual rate of
basic pay prescribed for level IV of the Executive Schedule
under section 5315 of title 5, United States Code, for each
day (including travel time) during which the member is
engaged in the actual performance of duties as a member of
the Board.
``(C) Travel expenses.--Each member of the Board shall
receive travel expenses, including per diem in lieu of
subsistence, in accordance with applicable provisions under
subchapter I of chapter 57 of title 5, United States Code.
``(D) Detail of government employees.--Any Federal
Government employee may be detailed to the Board with the
approval for the contributing agency without reimbursement,
and such detail shall be without interruption or loss of
civil service status or privilege.
``(b) Definitions.--Any term that is defined in section
319L and that is used in this section shall have the same
meaning in this section as such term is given in section
319L.
``(c) Authorization of Appropriations.--There are
authorized to be appropriated $1,000,000 to carry out this
section for each of the fiscal years 2007 and 2008.''.
SEC. 4. CLARIFICATION OF COUNTERMEASURES COVERED BY PROJECT
BIOSHIELD.
(a) Qualified Countermeasures.--Section 319F-1(a)(2) of the
Public Health Service Act (42 U.S.C. 247d-6a(a)(2)) is
amended--
(1) by amending subparagraph (A) to read as follows:
``(A) diagnose, mitigate, prevent, or treat harm from any
biological agent (including organisms that cause an
infectious disease) or toxin, or from any chemical,
radiological, or nuclear agent, that may cause a public
health emergency affecting national security; or'';
(2) in subparagraph (B), by striking ``treat, identify, or
prevent harm'' and inserting ``diagnose, mitigate, prevent,
or treat harm''; and
(3) by adding after and below subparagraph (B) the
following:
``If through publication in the Federal Register the
Secretary makes a determination that there is credible
evidence that a biological agent has the potential to cause
an epidemic or pandemic that may constitute a public health
emergency, a countermeasure to such agent shall, without
further administrative action, be considered a qualified
countermeasure within the meaning of this paragraph.''.
(b) Security Countermeasures.--Section 319F-
2(c)(1)(B)(i)(I) of the Public Health Service Act (42 U.S.C.
247d-6b(c)(1)(B)(i)(I)) is amended by striking ``to treat''
the first place such term appears and all that follows
through ``from a condition'' and inserting the following:
``to diagnose, mitigate, prevent, or treat harm from any
biological agent (including organisms that cause an
infectious disease) or toxin or from any chemical,
radiological, or nuclear agent identified as a material
threat under paragraph (2)(A)(ii), or to diagnose, mitigate,
prevent, or treat harm from a condition''.
SEC. 5. TECHNICAL ASSISTANCE.
Subchapter E of chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding
at the end the following:
``SEC. 565. TECHNICAL ASSISTANCE.
``The Secretary, in consultation with the Commissioner of
Food and Drugs, shall establish within the Food and Drug
Administration a team of experts on manufacturing and
regulatory activities (including compliance with current Good
Manufacturing Practice) to provide both off-site and on-site
technical assistance to the manufacturers of qualified
countermeasures (as defined in section 319F-1 of the Public
Health Service Act), security countermeasures (as defined in
section 319F-2 of such Act), or vaccines, at the request of
such a manufacturer and at the discretion of the Secretary,
if the Secretary determines that a shortage or potential
shortage may occur in the United States in the supply of such
vaccines or countermeasures and that the provision of such
assistance would be beneficial in helping alleviate or avert
such shortage.''.
SEC. 6. PROCUREMENT.
Section 319F-2 of the Public Health Service Act (42 U.S.C.
247d-6b) is amended--
(1) in the section heading, by inserting ``AND SECURITY
COUNTERMEASURE PROCUREMENTS'' before the period; and
(2) in subsection (c)--
(A) in the subsection heading, by striking ``Biomedical'';
(B) in paragraph (5)(B)(i), by striking ``to meet the needs
of the stockpile'' and inserting ``to meet the stockpile
needs'';
(C) in paragraph (7)(B)--
(i) by striking the subparagraph heading and all that
follows through ``Homeland Security Secretary'' and inserting
the following: ``Interagency agreement; cost.--The Homeland
Security Secretary''; and
(ii) by striking clause (ii);
(D) in paragraph (7)(C)(ii)--
(i) by amending clause (I) to read as follows:
``(I) Payment conditioned on delivery.--The contract shall
provide that no payment may be made until delivery of a
portion, acceptable to the Secretary, of the total number of
units contracted for, except that, notwithstanding any other
provision of law, the contract may provide that, if the
Secretary determines (in the Secretary's discretion) that an
advance payment, partial payment for significant milestones,
or payment to increase manufacturing capacity is necessary to
ensure success of a project, the Secretary shall pay an
amount, not to exceed 10 percent of the contract amount, in
advance of delivery. The Secretary shall, to the extent
practicable, make the determination of advance payment at the
same time as the issuance of a solicitation. The contract
shall provide that such advance payment is required to be
repaid if there is a failure to perform by the vendor under
the contract. The contract may also provide for additional
advance payments of 5 percent each for meeting the milestones
specified in such contract. Provided that the specified
milestones are reached, these advance payments of 5 percent
shall not be required to be repaid. Nothing in this subclause
shall be construed as affecting the rights of vendors under
provisions of law or regulation (including the Federal
Acquisition Regulation) relating to the termination of
contracts for the convenience of the Government.''; and
(ii) by adding at the end the following:
``(VII) Procurement of multiple products and
technologies.--The Secretary may enter into multiple
transactions for the procurement of multiple technologies and
products from multiple manufacturers of security
countermeasures in order to mitigate against the risks
associated with dependence on a single supplier or
technology.
``(VIII) Sales exclusivity.--The contract may provide that
the vendor is the exclusive supplier of the product to the
Federal Government for a specified period of time, not to
exceed the term of the contract, on the condition that the
vendor is able to satisfy the needs of the Government. During
the agreed period of sales exclusivity, the vendor shall not
assign its rights of sales exclusivity to another entity or
entities without approval by the Secretary. Such a sales
exclusivity provision in such a contract shall constitute a
valid basis for a sole source procurement under section
303(c)(1) of the Federal Property and Administrative Services
Act of 1949 (41 U.S.C. 253(c)(1)).
``(IX) Surge capacity.--The contract may provide that the
vendor establish domestic manufacturing capacity of the
product to ensure that additional production of the product
is available in the event that the Secretary determines that
there is a need to quickly purchase additional quantities of
the product. Such contract may provide a fee to the vendor
for establishing and maintaining such capacity in excess of
the initial requirement for the purchase of the product.
Additionally, the cost of maintaining the domestic
manufacturing capacity shall be an allowable and allocable
direct cost of the contract.
``(X) Additional contract terms.--The Secretary, in any
contract for procurement under this section, may specify--
``(aa) the dosing and administration requirements for
countermeasures to be developed and procured;
``(bb) the amount of funding that will be dedicated by the
Secretary for development and acquisition of the
countermeasure; and
``(cc) the specifications the countermeasure must meet to
qualify for procurement under a contract under this
section.''; and
(E) in paragraph (8)(A), by adding at the end the
following: ``In the case of such agreements by the Secretary,
the Secretary may allow other executive agencies to order
qualified and security countermeasures under procurement
contracts or other agreements established by the Secretary,
and such ordering process (including transfers of
appropriated funds between an agency and the Department of
Health and Human Services as reimbursements for such orders
for countermeasures) may be conducted under the authority of
section 1535 of title 31, United States Code, except that all
such orders shall be processed under the terms established
under this section for the procurement of countermeasures.''
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Georgia (Mr. Deal) and the gentlewoman from California (Ms. Eshoo) each
will control 20 minutes.
The Chair recognizes the gentleman from Georgia.
General Leave
Mr. DEAL of Georgia. Mr. Speaker, I ask unanimous consent that all
Members may have 5 legislative days within which to revise and extend
their remarks on this legislation and insert extraneous material on the
bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Georgia?
There was no objection.
[[Page H7448]]
Mr. DEAL of Georgia. Mr. Speaker, I yield myself such time as I may
consume.
I rise today in strong support of H.R. 5533, the Biodefense and
Pandemic Vaccine and Drug Development Act of 2006.
Like the NIH Reform Act that we will be considering later this
evening, this legislation is the end product of a cooperative,
bipartisan effort to help improve research outputs for the benefit of
all Americans should the unspeakable happen here again on American
soil.
As my colleagues are no doubt aware, biodefense is an area where the
Federal Government must take a strong role because there is no business
model that will support the investments we need without a clear path
from the Federal Government. However, we also know that the expertise
in this area mostly lies with the private sector, so we must make sure
that we facilitate a strong working partnership.
Project BioShield was signed into law on July 21, 2004, to help
encourage the development of new bioterrorism countermeasures. The
legislation provided procedures for bioterrorism-related procurement,
hiring and awarding of research grants in an effort to make it easier
for United States Department of Health and Human Services to quickly
commit substantial funds to countermeasure projects.
This past April, the Subcommittee on Health held a hearing on Project
BioShield; and at this hearing our expert witnesses identified a number
of barriers to fully realizing Project BioShield's potential. They
highlighted the fact that there is no single point of authority within
the Department of Health and Human Services for the advanced research
and development of medical countermeasures to make important
procurement decisions. Additionally, HHS has limited purchasing and
contractual flexibility, and this inefficient structure and limited
flexibility exacerbates the shortcomings of the status quo.
Drug and vaccine development is unnecessarily lengthy, often taking
between 8 and 12 years, and many potential products fail prematurely
following basic research due to limited funding for advanced research
and development. There simply is not enough motivation for academic
researchers, drug and vaccine manufacturers and other possible partners
to commit substantial resources to bring new and improved products to
the market quickly.
I believe that the legislation before us today helps address the
problems raised in our hearing and represents a huge improvement over
the status quo.
I would like to commend the chairman of our Energy and Commerce
Committee, Chairman Barton of Texas; Congressman Mike Rogers of
Michigan; and Congresswoman Anna Eshoo of California for their strong
leadership on this legislation that builds on the achievements of the
Project BioShield Act and takes further steps to identify and promote
medical countermeasures to bioterrorism and other public health
emergencies, including potential pandemic infectious diseases.
I urge my colleagues to support this legislation.
Mr. Speaker, I reserve the balance of my time.
Ms. ESHOO. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I am really proud to be the Democratic sponsor of this
bill; and I want to salute my friend and my colleague, Representative
Rogers, for the work that he has done. We have really enjoyed working
together, and I think that the best part of this all is that our work
has really produced something that is important for the American
people. So I want to thank him for everything that he has done to see
that the bill is on the floor today.
This legislation really addresses a very urgent issue which is
critical to our Nation's security and our public health.
A month after the 9/11 attacks on New York and Washington, our
country was attacked again. When we were attacked that second time, it
was when envelopes of anthrax spores were mailed to several media
outlets and congressional offices. The attacks killed five people, they
crippled our mail service here on the Hill and cost hundreds of
millions of dollars to clean up.
We are now observing the spread of a virulent new strain of Avian
influenza, the so-called Asian bird flu, in Asia and around the world,
causing nearly 150 deaths and threatening to become the next deadly
pandemic.
Whether the threat is man-made bioterrorism or a highly infectious
disease, our country is at risk, and we are losing precious time in the
race to develop effective countermeasures that could save thousands or
even millions of lives.
In hearings earlier this year on the Project BioShield Act, it was
apparent that gaps remained in our effort to address these threats to
the public health.
In particular, we learned that very few companies are willing to risk
their limited resources to develop the vaccines and the antidotes to
respond to chemical, biological, radiological or nuclear attacks or to
a fast-spreading influenza.
Given the risks and the costs involved, it is not surprising that
companies would rather pursue the next blockbuster cancer medicine or
cholesterol medicine rather than take a chance on an uncertain market
where the government is likely to be the only customer.
So having heard this in the hearings, we rolled our sleeves up. We
understood that Project BioShield does not address the problem. While
the law set aside $5.6 billion over 10 years to obtain drugs for the
Strategic National Stockpile, companies receive very little
compensation until they can deliver a minimum number of doses. As a
result, many of these potential drugs languish in the laboratory in
what is known as the ``Valley of Death.''
As with any drug, the development of biodefense drugs require
efficacy trials, toxicity testing, production design and a range of
other activities that are expensive but necessary to determine whether
a drug will work, whether it is safe and how it will be manufactured.
The centerpiece of this legislation that we are on the floor on
behalf of this evening develops a new, or places a new office within
HHS, the Biomedical Advanced Research and Development Authority, BARDA,
which would be a single point of Federal authority for the development
of medical countermeasures.
This bill will empower BARDA to make milestone payments to drug
developers at key stages of their work, helping to reduce financial
risks of taking on this great challenge. In other words, we are going
to get the job done.
I urge my colleagues to support this important legislation, which
will ensure that our country does its best to prepare for the worst.
Mr. Speaker, I reserve the balance of my time.
Mr. DEAL of Georgia. Mr. Speaker, I am pleased to yield 5 minutes to
the gentleman from Michigan (Mr. Rogers), the author of the
legislation.
Mr. ROGERS of Michigan. Mr. Speaker, I rise today in strong support
of H.R. 5533, the Biodefense and Pandemic Vaccine and Drug Development
Act of 2006.
I would like to thank Chairman Barton and Chairman Deal and the
Energy Committee staff for their continued support on this effort.
I want to thank my colleague and friend, Congresswoman Anna Eshoo,
and her staff for your commitment, your energy, your counsel and your
enthusiasm to get this bill as far as we have come. Thank you very
much. It has been a joy to work with you.
And I have to say at the time of this intense pre-election
partisanship, I am thankful that we might serve as an example to many,
that you can reach across the aisle to pass important legislation that
affects the American people so deeply as their future security, the
security of their children and their families and the well-being of the
United States of America. Thank you for working with us. I appreciated
the opportunity to do that.
I would also like to recognize the administration and their
willingness to work with us to build upon Project BioShield, of which
they really led the charge. We found that it was not sufficient, it
needed some improvement, but it was very forward leaning of this
President to come out and establish for the first time BioShield,
knowing that the threat was real from terrorists around the country and
trying to develop at least a program that would deal with the bioterror
threat to the
[[Page H7449]]
United States. They have been so willing to work with us in finding out
what worked and what did not work and this second round we think
improves BioShield dramatically and really has to happen if we are
going to have protection against biothreats in the future.
The efforts include both offensive and defensive ways to find new
developments and better treatments for those infected by bioterrorist
attacks and naturally occurring attacks, as was mentioned by the
mention of the bird flu.
The problems that we have discovered in looking at BioShield was that
there was no single point of authority within HHS for the advanced
research and development of countermeasures and quick procurement
decisions, and, really, there is only one customer for these type of
vaccines, and this is the place where we found some difficulty. There
is really only one customer, and that customer is the people of the
United States, the government of the United States. With a single
source contract it is very hard to attract venture capital, very hard
to get private industry excited about developing something if they did
not know where the Federal Government was going to be when it came to
purchasing something that we are the only ones that were going to buy
it, a hard place to be.
So we came up with the single point of authority to make quick
decisions; and the Valley of Death takes a long time, 8 to 12 years, to
develop these vaccines, very labor intensive, a lot of intellectual
power applied to coming up with the right vaccine to be the right
prophylactic for what we know is a bioterrorism or natural-occurring
event. That Valley of Death, because we are the single source of those
contracts, was very real and stalling what we know is great research to
happen for the cure and the development of these vaccines.
Also, we found that it did not motivate academic researchers, drug
and vaccine manufacturers and other possible partners to commit
substantial resources.
{time} 2000
What this bill does, Mr. Speaker, is address all those issues and
gives us a framework to go forward and bring out the best in our
scientific community, our academic community, our producing community
to come up with the right safety net for the protection of the United
States when it comes to bioterror threats and natural occurring threats
in and around our societies, which we know is already here, bird flu
mentioned, but we also know the real threat of bioterrorism as well.
I would hope, Mr. Speaker, that we could encourage the Senate to take
our lead here and set aside any partisanship that may arise in the
course of this bill in the Senate and take quick action. This really
means the safety and security of every family in this country.
Bioterrorism is, unfortunately, a reality in 2006 and beyond; and they
need to set aside any differences they may have in the Senate and take
this bill up. So I would encourage Senate Democrat leadership to do
just that.
I would also commend Senator Byrd, who has created this bipartisan
product, and urge they move this product as soon as possible. And I
would also urge, Mr. Speaker, that this important piece of legislation
be passed as quickly as possible.
Ms. ESHOO. Mr. Speaker, I just want to close. I do not think I have
any other individuals to come to the floor to speak on this this
evening.
I also want to thank our staffs, because they have worked exceedingly
hard and exceedingly well with one another, both from Mr. Rogers'
staff, certainly mine, with Steve Keenan and Jennifer Nieto, and
everyone that helped them in my office, as well as John Ford on the
minority staff of the committee, as well as the majority staff. I
salute all of you. I thank you. I am proud of the work we have been
able to do.
Mr. DINGELL. Mr. Speaker, I rise in support of H.R. 5533, the
``Biodefense and Pandemic Vaccine and Drug Development Act of 2006''.
In an effort to respond to the new era of heightened threats to our
national security and the increased risk of harm to Americans, Congress
passed the ``Project Bioshield Act'' in July of 2004. The basic purpose
of Project Bioshield was to support research that would lead to the
development and availability of ``countermeasures'' to combat public
health emergencies that threaten our national security. The main
provisions of this law included: (1) flexible procedures for
bioterrorism-related procurement, hiring of personnel, and awarding of
research grants; (2) guaranteeing a Federal Government market for new
biomedical countermeasures; and (3) permitting emergency use of
unapproved countermeasures.
Building on the Project Bioshield Act, H.R. 5533 takes further steps
to identify potential medical countermeasures to protect the public
health and national security from biological, chemical, radiological,
and nuclear threats. Additionally, this legislation ensures the rapid
development of medical countermeasures against such threats, including
potential pandemic infectious diseases and it seeks to expand the
collaboration and coordination between government and the private
sector so that we can effectively respond in the event of a public
health emergency.
Since the implementation of Project Bioshield, it has become apparent
that certain barriers still exist to the development of
countermeasures. Many promising countermeasures are not making it
through the advanced research and development stages necessary to bring
products to the point of eligibility for procurement. H.R. 5533 seeks
to rectify this impediment to advanced-stage countermeasure
development.
This legislation seeks to streamline the countermeasure research and
development process and create a single point of Federal authority by
creating a new office called the Biomedical Advanced Research and
Development Agency (BARDA) within the Department of Health and Human
Services. BARDA would establish a ``one stop shop'' agency for advanced
research and development of medical countermeasures, including drugs
and vaccines to respond to bioterrorism and natural disease outbreaks.
This agency would be responsible for directing and coordinating
collaboration among HHS entities, other Federal agencies, relevant
industries, academia, and other individuals with respect to
countermeasure research and development.
I commend my colleagues, Representatives Eshoo and Rogers, for their
diligent and impassioned work on this issue. This is a good bill and I
urge my colleagues to support it.
Mr. BARTON of Texas. Mr. Speaker, please include this exchange of
correspondence in the Record for H.R. 5533.
House of Representatives,
Committee on Energy and Commerce,
Washington, DC, September 26, 2006.
Hon. Tom Davis,
Chairman, Committee on Government Reform,
House of Representatives, Washington, DC.
Dear Chairman Davis: I acknowledge and appreciate your
willingness not to exercise your referral of H.R. 5533,
Biodefense and Pandemic Vaccine and Drug Development Act of
2006. In doing so, I agree that your decision to forgo
further action on the bill will not prejudice the Committee
on Government Reform with respect to its jurisdictional
prerogatives on this legislation or similar legislation.
Further, I recognize your right to request conferees on
those provisions within the Committee on Government Reform's
jurisdiction should they be the subject of a House-Senate
conference on this or similar legislation.
I will include your letter and this response in the
Congressional Record during floor consideration of H.R. 5533.
Sincerely
Joe Barton,
Chairman.
____
House of Representatives,
Committee on Government Reform,
Washington, DC., September 26, 2006.
Hon. Joe Barton,
Chairman, House Committee on Energy and Commerce,
Rayburn House Office Building, Washington, DC.
Dear Mr. Chairman: On September 20, 2006, the House
Committee on Energy and Commerce reported H.R. 5533, the
Biodefense and Pandemic Vaccine and Drug Development Act of
2006. As you know, the bill includes provisions within the
jurisdiction of the Committee on Government Reform,
specifically section 3 of the bill that would exempt the
Authority proposed to be created by this legislation from
portions of the Federal Advisory Committee Act and the
Freedom of Information Act. Section 3 would also authorize
the Secretary of Health and Human Services to utilize ``other
transaction'' procurement authority.
In the interests of moving this important legislation
forward, I agreed to waive sequential consideration of this
bill by the Committee on Government Reform. However, I did so
only with the understanding that this procedural route would
not be construed to prejudice the Committee on Government
Reform's jurisdictional interest and prerogatives on this
bill or any other similar legislation and will not be
considered as precedent for consideration of matters of
jurisdictional interest to my Committee in the future.
I respectfully request your support for the appointment of
outside conferees from the
[[Page H7450]]
Committee on Government Reform should this bill or a similar
bill be considered in a conference with the Senate. Finally,
I request that you include this letter and your response in
the Congressional Record during consideration of the
legislation on the House floor.
Thank you for your attention to these matters.
Sincerely,
Tom Davis.
Mr. WAXMAN. Mr. Speaker, the bill before us would create a new agency
within the Department of Health and Human Services, the Biomedical
Advanced Research and Development Authority, or BARDA. I support
creating this new agency. However, some provisions in the bill raise
concerns because they waive a number of existing Federal statutes
enacted to ensure proper government oversight. I want to express my
reservations over these provisions, and urge that they be addressed in
conference.
This bill contains exemptions from important federal open government
laws designed to ensure accountability and transparency, like the
Freedom of Information Act (FOIA) and federal procurement law. These
open government laws are within the jurisdiction of the Committee on
Government Reform, on which I am the ranking member, but unfortunately,
the Government Reform Committee did not have an opportunity to consider
the bill.
FOIA is the central law that guarantees public access to government
information. It establishes the presumption that people should be able
to access information held by the government. FOIA contains exemptions
that prevent the disclosure of information in the case where harm could
result from disclosure--including exemptions for classified
information, trade secrets, information compiled for law enforcement
purposes, and internal agency documents that would be exempt from
discovery in litigation.
H.R. 5533 establishes a new FOIA exemption, requiring the Secretary
to withhold from public disclosure ``specific technical data of
scientific information that is created or obtained during
countermeasure research and product advanced development funded by the
Secretary that reveal vulnerabilities of existing medical or public
health defenses against biological, chemical, nuclear, or radiological
threats.'' While this exemption appears narrow in scope, the
Administration has a long record of interpreting narrow language
broadly to withhold public information. Unless there is a compelling
reason why the existing FOIA exemptions are inadequate--which there
does not appear to be in this case--it is unwise to add new exemptions
to FOIA. Moreover, the language of the new exemption is not clear. The
language applies to any ``advanced research and development that is
funded by the Secretary,'' which may inappropriately extend the
exemption far beyond BARDA to other research funded by the Department
of Health and Human Services.
Another issue is so-called ``other transaction authority.'' This
authority is essentially a waiver from most federal procurement law--
everything from competition requirements, to auditing and pricing
safeguards, to the Buy America and Drug-free workplace laws. The
authority was originally developed to help DOD in attracting smaller
contractors to federal research and development contracts, though in
practice it has not often been used to accomplish that objective. While
I am not necessarily opposed to granting BARDA other transaction
authority, I have yet to hear a convincing rationale for its necessity.
If such a rationale exists, we should explore ways to limit its
application at BARDA to those instances where it is truly needed, as
opposed to the blanket grant of authority currently in H.R. 5533.
Finally, H.R. 5533 exempts all advisory committees established under
the bill from section 14 of the Federal Advisory Committee Act. Section
14 was added to the FACA law because Congress decided that there was a
proliferation of advisory committees and that it is important to ensure
that they should continuously be reviewed to ensure their ongoing
necessity. Again, there is no clear explanation for why this waiver of
current law is necessary, or what interests would be protected by
exempting the committees from renewal requirements.
All of these issues are within the jurisdiction of the Government
Reform Committee, and I hope they can be addressed as this bill moves
forward in the legislative process.
Ms. ESHOO. Mr. Speaker, I yield back the balance of my time.
Mr. DEAL of Georgia. Mr. Speaker, I have no other requests for time,
and I yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Georgia (Mr. Deal) that the House suspend the rules and
pass the bill, H.R. 5533, as amended.
The question was taken; and (two-thirds having voted in favor
thereof) the rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
____________________